Real-world Study of Taletrectinib in Advanced ROS1+ NSCLC Following Entrectinib Progression

NCT07199010 | Not Yet Recruiting

• 1 other identifier: IBI344-RWS-001
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This is a multicenter, non-interventional, observational real-world study to evaluate the efficacy and safety of Taletrectinib in ROS1-positive non-small cell lung cancer (NSCLC) following Entrectinib progression. Patients deemed eligible for Taletrectinib by their physicians were enrolled after providing informed consent. Taletrectinib will be administered according to clinical practice and data on treatment patterns, clinical outcomes, and safety will be collected during routine evaluations.

Conditions

Non-small Lung Cancer

Outcome Measures

Primary Outcomes (1)

• ORR

  Objective response rate

  6 months

Secondary Outcomes (9)

• PFS

  25 months

• DoR

  25 months

• DCR

  6 months

• OS

  51 months

• iORR

  6 months

Study Arms (1)

Cohort 1

ROS1 fusion positive NSCLC patients following Entrectinib progression who received taletrecitnib

Drug: Taletrectinib

Interventions

Taletrectinib DRUG

Taletrectinib, 600mg, QD

Also known as: AB-106, DS-6051b

Cohort 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with ROS1-positive non-small cell lung cancer (NSCLC) who progressed following Entrectinib treatment

You may qualify if:

• Age ≥ 18 years.
• Histologically or cytologically metastatic NSCLC (UICC/AJCC TNM Staging System, 9th Edition, Stage Ⅳ).
• At least one measurable target tumor lesion as accessed by RECIST v1.1 criteria.
• Documented ROS1 gene fusion identified by an approved molecular testing method (FISH, RT-PCR, or NGS).
• Progressed following entrectinib treatment, regardless of prior exposure to chemotherapy, antiangiogenic multikinase inhibitors, or immunotherapy.
• Considered by the investigator to be candidates for Taletrectinib treatment ; OR Patients with ≤6 months of prior Taletrectinib exposure enrolled retrospectively. (Note: For retrospective patients deceased before enrollment, waiver of informed consent is required. Patients who initiated and discontinued treatment within 6 months prior to signing informed consent are eligible).
• Signed Informed Consent.

You may not qualify if:

• Patients with driver gene mutations/alterations that have approved targeted therapies , including but not limited to EGFR, ALK, RET, etc.
• Currently participating in other interventional clinical trials or having received investigational drug treatment within 4 weeks prior to enrollment .
• Pregnancy or breastfeeding.
• Patients with uncontrolled co-morbidities who are assessed by the investigator not to receive targeted therapy.
• Other conditions that are assessed by the investigator to be unsuitable for enrollment in this study.

Sponsors & Collaborators

• Innovent Biologics (Suzhou) Co. Ltd.: lead

Study Sites (1)

Shanghai East Hospital (The East Hospital Affiliated to Tongji University)

Shanghai, Shanghai Municipality, 200120, China

Location

MeSH Terms

Interventions

taletrectinib

Central Study Contacts

Joshua GUO

CONTACT

+86-18819430923; joshua.guo@innoventbio.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2025
• First Posted: September 30, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: September 30, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)